Usage Monitoring Attachment for Medicament Dispenser

ABSTRACT

Systems and methods are described for monitoring usage of a medicament dispenser—particularly an inhaled medicament dispenser. While operating in a low-power mode, a first sensor is monitored for a signal indicative of handling of the medicament dispenser by a user. In response to detecting such handling, the device exits the low-power mode and begins to monitor a second sensor for a signal indicative of dispensing of the medicament. The usage monitoring device can be embodied as an attachment configured to be selectively coupled to one of a variety of different inhalers including, for example, a Diskus-type inhaler and a Respimat-type inhaler.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of prior, co pending U.S. applicationSer. No. 14/770,078, filed on Aug. 24, 2015, which is a National StageEntry of International Application No. PCT/US2014/039014, filed on May21, 2014 which claims the benefit of and priority to U.S. ProvisionalApplication No. 61/825,668, filed on May 21, 2013, all of which areincorporated herein by reference in their entirety for all purposes.

BACKGROUND

This The present invention relates to systems and methods for monitoringthe usage of a medication. In particular, the invention relates tomethods of monitoring usage of a dispenser, such as an inhaler, thatprovides a dose of medication to a patient.

SUMMARY

In one embodiment, the invention provides an attachment component thatis selectively connectable to a medication dispenser. The attachmentcomponent includes a controller in communication with an accelerationsensor, at least one infrared sensor, and a microphone. The controllermonitors the acceleration sensors and, when the acceleration exceeds athreshold, the controller provides power to the infrared sensors. Thecontroller then monitors the infrared sensor to determine whether adispenser cover is opened. When the dispenser cover is opened, thecontroller monitors the acceleration sensor to detect an accelerationassociated with a priming of the dispenser. In some embodiments, the“priming” includes activating a mechanism to release a dose of amedication from a packaging. In other embodiment, the “priming” includesa rapid shaking of a medication canister. After the priming action isdetected, the controller activates the microphone and records an audiosignal for a defined duration of time. In some embodiments, thecontroller terminates recording when the infrared sensors indicate thatthe dispenser cover is closed.

In some embodiments, the controller performs one or more audioprocessing operations on the recorded audio signal. In some embodiments,the controller transmits the audio recording or data indicative of theaudio record through a wireless transceiver device to a portabletelephone. In some embodiments, the attachment further includes a wireddata port for connecting the attachment to an external device such as apersonal computer. When the wired data port is connected to the externaldevice, the controller transmits the audio recording or data indicativeof the audio recording through the wired data port.

In one embodiment, the invention provides a method of monitoring usageof a medicament dispenser. While operating in a low-power mode, a firstsensor is monitored to detect handling of the medicament dispenser by auser. Once handling of the dispenser is detected, the low-power mode isexited and power is applied to a second sensor. The second sensor isthen monitored for a signal indicative of dispensing of the medicament.

In another embodiment, the invention provides a method of monitoringusage of a medicament dispenser. A monitoring attachment is coupled to amedicament dispenser such that the monitoring attachment does notinterfere with dispensing of medicament from the medicament dispenser.The monitoring attachment is operated in a low-power mode, wherein poweris applied to an acceleration sensor positioned within the monitoringattachment when in the low power mode and power is not applied to asecond sensor positioned within the monitoring attachment when in thelow-power mode. While operating in the low-power mode, the accelerationsensor is monitored and the output is compared to an accelerationthreshold. When the output of the acceleration sensor exceeds theacceleration threshold, the attachment determines that the medicamentdispenser (and the attachment) is being handled by a user. In response,the attachment exits the low-power mode and applies power to the secondsensor. The second sensor is then monitored for a signal indicative ofdispensing of a medicament from the medicament dispenser in response todetermining that the monitoring attachment is being handled by the user.In response to detecting the signal indicative of the dispensing ofmedicament, the attachment transmits a signal through its wirelesstransmitter indicative of the dispensing of the medicament.

In various embodiments, the attachment is configured to be selectivelycoupled to different specific inhaler types including, for example, aDiskus-type dry-powder inhaler or a Respimat-type soft mist inhaler.

In yet another embodiment, the invention provides an attachment formonitoring usage of a medicament dispenser. The attachment includes ahousing that is selectively coupleable to the medicament dispenserwithout affecting the operation of the medicament dispenser. A firstsensor, a second sensor, and a wireless transmitter are fixedly coupledto the housing. The attachment also includes a processor and memory. Theattachment operates in a low-power mode where power is applied to thefirst sensor and power is not applied to the second sensor. While in thelow-power mode, the attachment monitors the first sensor for a signalindicative of handling of the medicament dispenser while operating inthe low-power mode. In response to detecting such a signal, theattachment exits the low-power mode, applies power to the second sensor,and monitors the second sensor for a signal indicative of dispensing ofthe medicament from the dispenser. Once the dispensing is detected, theattachment transmits a signal indicative of the dispensing through itswireless transmitter.

In some embodiments, the housing of the attachment includes an upperbody portion and a lower body portion. The upper and lower body portionsare connected by one or more side support structures and are sized toreceive a Diskus-type medicament dispenser between the upper bodyportion and the lower body portion such that the upper body portion ispositioned on a top surface of the substantially disc-shaped dispenserbody and the lower body portion is positioned on a bottom surface of thesubstantially disc-shaped dispenser body.

Other aspects of the invention will become apparent by consideration ofthe detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an overhead view of a medication dispenser in a closedposition.

FIG. 1B is an overhead view of the medication dispenser of FIG. 1A in anopened position.

FIG. 2 is a perspective view of an attachment for monitoring usage ofthe medication dispenser of FIG. 1A according to one embodiment.

FIG. 3 is a block diagram of various components of the attachment ofFIG. 2.

FIG. 4 is a flowchart of a method for monitoring usage of a medicationdispenser using the attachment of FIG. 2.

FIG. 5 is a state diagram illustrating various operating states of theattachment of FIG. 2.

FIG. 6A is a perspective view of an attachment for use with a dry-powderinhaler.

FIG. 6B is a top view of the attachment of FIG. 6A.

FIG. 6C is a bottom view of the attachment of FIG. 6A.

FIG. 6D is a right side view of the attachment of FIG. 6A.

FIG. 6E is a left side view of the attachment of FIG. 6A.

FIG. 6F is a front view of the attachment of FIG. 6A.

FIG. 6G is a rear view of the attachment of FIG. 6A.

FIG. 7A is cross-sectional view of another construction of an attachmentfitted to a soft mist inhaler (SMI).

FIG. 7B is an exploded view of the attachment and soft mist inhaler(SMI) of FIG. 7A.

FIG. 8A is a perspective view of another attachment for a soft mistinhaler (SMI).

FIG. 8B is a front view of the attachment of FIG. 8A.

FIG. 8C is a rear view of the attachment of FIG. 8A.

FIG. 8D is a left side view of the attachment of FIG. 8A.

FIG. 8E is a right side view of the attachment of FIG. 8A.

FIG. 8F is a top view of the attachment of FIG. 8A.

FIG. 8G is a bottom view of the attachment of FIG. 8A.

DETAILED DESCRIPTION

Before any embodiments of the invention are explained in detail, it isto be understood that the invention is not limited in its application tothe details of construction and the arrangement of components set forthin the following description or illustrated in the following drawings.The invention is capable of other embodiments and of being practiced orof being carried out in various ways.

FIG. 1A illustrates an example of a device 100 for dispensing an inhaledmedication such as the Advair Diskus® dry powder inhaler (DPI). Thedispenser 100 includes a dispenser body 101, a thumb grip 103, and adose counter 105. A rotatable cover 107 is rotatably connected to thedispenser body 101. To place the dispenser device 100 in the “open”position, a user places her thumb in the thumb grip 103 and rotates thedispenser body 101 relative to the dispenser cover 107 as indicated bythe arrow.

FIG. 1B shows the dispenser device 100 in the open position. Because thedispenser body 101 has been rotated relative to the cover 107, the thumbgrip 103 and the dose counter 105 are now shown on the opposite side ofthe device 100. When in the open position, a priming lever 109 and amouthpiece 111 of the device 100 are uncovered.

To use the dispenser device shown in FIGS. 1A and 1B, a patient rotatesthe dispenser body 101 into the “open” position and moves the priminglever 109 as indicated by the arrow in FIG. 1B. Moving the priming lever109 causes a dose of medication to be removed from packaging storedwithin the device body 101. In some constructions, moving the priminglever 109 both removes a medication from a packaging and crushes apill-form medication into an inhalable powder. The patient then placestheir mouth on the mouthpiece 111 and inhales the medication from thedispenser 100.

FIG. 2 illustrates an attachment device 200 that monitors usage of thedispenser 100. Data collected from the attachment device 200 can be usedto track the time, date, and location of regular uses of a medicamentdispenser, such as described in U.S. Pub. No. 2009/0194104, filed onJan. 5, 2009 and entitled “DEVICE AND METHOD TO MONITOR, TRACK, MAP, ANDANALYZE USAGE OF METERED-DOSE INHALERS IN REAL-TIME.” Alternatively, thecollected data can be analyzed to confirm that the medication is beingtaken appropriately. For example, the data can be analyzed to verifythat the medication is being taken at the appropriate times asprescribed by the doctor. Furthermore, as described in further detailbelow, the audio signal recorded during usage can be analyzed to ensurethat the medication is being properly inhaled and, in some cases, toconfirm that the proper medication is being used.

As shown in FIG. 2, the attachment device 200 includes an upper body 201with two leg portions 203,205 extending from the upper body 201 andreconnecting at a lower ring body 207. A medication dispenser, such asdispenser 100 illustrated in FIGS. 1A & 1B is selectively insertableinto the cavity formed by the upper body 201, the leg portions 203,205,and the lower ring body 207. The attachment device 200 is also waterproof (or water resistant) to protect the electronics housed within. Theattachment device 200 is constructed of a bio-compatible material thatwill not adversely affect the medication being dispensed and will notadversely affect the patient using the device 200.

The attachment device 200 is sized to receive the dispenser 200 and holdthe dispenser in place by friction. In some constructions, all externalsurfaces of the attachment device 200 are constructed of a rigid plasticmaterial. However, in some alternative constructions, the leg portions203, 205 are construction of a flexible and stretchable material toallow the attachment device to better conform to the dispenser and toincrease friction between the attachment and the dispenser.

The attachment device 200 is sized and shaped so that it does notinterfere with the operation and actuation of the medication dispenseror with the dispensed medication. The priming lever 109 is able to movefreely and access to the mouthpiece 111 is not obstructed. When thereare no more medication doses remaining in the dispenser 100, thedispenser 100 can be removed from the attachment device 200 and replacedwith a new dispenser 100. The opening in the lower ring body 207provides access to the dispenser 100, making it easier for the dispenser100 to be removed. In some constructions, color coding is used to ensurethat the correct dispenser is used and that the dispenser is properlyinserted into the attachment device 200.

The attachment device 200 also includes a “cassette” portion 209. The“cassette” portion 209 houses the electronics of the attachment device200 as described below and can be removed from the upper body 201 of theattachment device 200. The cassette portion 209 includes a protrusion211 that extends from the upper body 201 when the cassette portion 209is properly installed. The protrusion 211 positions varioussensors—including a pair of infrared sensors that detect whether thedispenser 100 is in the open (FIG. 1B) or closed position (FIG. 1A).

FIG. 3 illustrated the electronic components housed within the cassetteportion 209 of the attachment device 200. Although, in this example, theelectronics can be removed from the attachment device 200 by removingthe cassette portion 209, in other constructions, the electronics can bepermanently housed within the upper body 201 or elsewhere in theattachment device 200.

The cassette portion 209 includes a processor 301 which controls theoperation of the attachment device 200. In various constructions, theprocessor 301 can include a microcontroller, microprocessor, ASIC, orother circuitry. However, in this particular example, the processor 301accesses software instructions stored on a memory 303 and executes theinstructions to control the operation of the attachment device 200. Thememory 303 can include, for example, one or more transitory ornon-transitory memory components such as random access memory (“RAM”),read-only memory (“ROM”), flash memory, and other magnetic memory media.In this example, the memory module 303 includes a non-volatile memorythat retains stored data when power is lost (or intentionally removed).

The processor 301 is connected to three sensor modules—an accelerometer305, an IR sensor module 307, and a microphone 309. The accelerometer305 measures accelerations applied to the attachment device 200 causedby movements of the device. Furthermore, as described in detail below,the accelerometer 305 may be positioned and configured to detect animpulse caused by the movement of the priming lever 209. Theaccelerometer 305 includes a low-power, 3-axis accelerometer that isbeing monitored at all times. Alternatively, the attachment device mayinclude one or more capacitive sensors to detect when the device isbeing handled.

The IR sensor module 307 includes a pair of infrared sensors positionedin the protrusion 211 of the attachment device 200. The IR sensors arepositioned to monitor movements of the device body 201 and to indicatewhether the dispenser is in an open position or a closed position. Inparticular, the IR sensor module monitors the position of the air intakeridges of the dispenser or the location of the dose counter window(depending on how the dispenser is inserted into the attachment device).Although the examples described herein include an IR sensor module, somealternative constructions will include other sensor mechanisms todetermine whether a dispenser is opened or closed. For example, amechanical switch or magnetic detection can be used to detect rotationof the dispenser body.

Alternatively, the attachment housing itself can be constructed of ametalized plastic material or with electrodes which would allow theentire body of the attachment device to operate as a capacitive sensor.Changes in capacitance could be monitored to indicate when the device isbeing handled—thereby also replacing the accelerometer. In addition, theelectrodes can sense when the patient lips are near or contacting themouthpiece.

The microphone 309 captures audio of the patient inhaling themedication. This audio data is processed by the processor 301 or by anexternal computer system to ensure appropriate medication usage.Furthermore, the microphone system 309 is configured to identify, note,and segregate inhalation events from other background noise. Themicrophone system 309 eventually adapts to eliminate false positives byrecognizing an audio signal that is associated with a user's uniqueinhalation. As the microphone system 309 is able to adapt based on“learned” data, the accuracy of the attachment device and its ability tocorrectly identify inhalation events is improved.

The processor 301 is also connected to a wireless transceiver 311 thatis configured to exchange data with an external device. In the exampleof FIG. 3, the wireless transceiver 311 communicates with a cellulartelephone 313 carried by the patient. The cellular telephone 313 furtherrelays information between the attachment device 200 and a remotecomputer server. The wireless transceiver in this example is aBluetooth-type transceiver. However, other constructions may include anyother type of wireless communication device including, for example,Wi-Fi, cellular, or RF transceivers.

The example of FIG. 3 shows the accelerometer 205, IR sensor module 307,microphone 309, and wireless transceiver 311 all directly connected tothe processor 301. However, it is to be understood that the attachmentdevice may include a controller area network (“CAN”) with a bus forrelaying data between the various components of the attachment device200. Other configurations and communication mechanisms are alsopossible.

Furthermore, although the example of FIG. 3 shows communication with thecomputer server 315 through a wireless relay with a cell phone 313carried by the user, other constructions may include other mechanismsfor transferring data between the attachment device 200 and the computerserver 315. For example, the attachment device 200 may be equipped witha cellular communication module for directly communicating with thecomputer server 315 over a cellular telephone network. Alternatively,the attachment device 200 may include a Wi-Fi transceiver forcommunicating with the computer server 315 through the Internet or othercomputer network. Furthermore, wired communication mechanisms can alsobe utilized. In some constructions, the attachment device includes awired data port. When the attachment device is directly connected to apersonal computer through the wired data port, the controller isconfigured to communicate with the computer through the wired data port.The wired data port can also be used to provide software/firmwareupdates to the attachment device.

FIG. 4 illustrates one example of a method of monitoring usage of thedispenser 100 using the attachment device 200. The method of FIG. 4 isstored as software instructions on the memory 303 and executed by theprocessor 301. The attachment device begins in a low-power “sleep mode”where the acceleration sensor is being monitored, but the IR sensormodule and the microphone are both disabled (step 401). The controllercontinuously compares the measured acceleration to an accelerationthreshold (step 403). Once the threshold is exceeded-indicatingexcessive movement of the dispenser device, the controller providespower to the IR sensors (step 405) and monitors the IR sensors todetermine whether the dispenser is in an open position or closedposition (step 407). Once the IR sensors indicate that the dispenser isin the open position, the controller monitors the acceleration sensorfor a motion impulse associated with activation of the priming lever(step 409). When the priming impulse is detected (step 411), thecontroller activates the microphone and begins recording audio data(step 413). The audio data is amplified, low-pass filtered, andconverted to digital data by a 12-bit analog-to-digital converter. Theraw digital data is stored to the memory and analyzed (e.g., FFT,cepstral coefficients, zero-crossing rate, average amplitude vs. time,envelope, etc.) to create a compressed set of metadata associated withthe recorded audio. The controller then wirelessly transmits thecompressed audio data to a cellular phone (step 415) which then sendsthe data to a computer server for further analysis and determination ofwhether a detected “usage event” was an actual dispense and inhalationof the medication. Alternatively, in some constructions, the raw,uncompressed audio data is sent to an external system where the audioprocessing and analysis is later performed.

To provide for more robust operation, the controller in someconstructions is programmed to operate in a number of “states” ratherthan executing a linear series of operations as illustrated in FIG. 4.FIG. 5 illustrates one example of a state diagram for controlling theoperation of the attachment device. The device begins in “Sleep Mode 1”(state 501) where the controller believes that the device cover isclosed. The accelerometer is turned on, but the IR sensor module and themicrophone are both disabled. When the acceleration exceeds a threshold,the system moves into a “waiting to open” state (state 503). In thisstate, the accelerometer and the IR sensor module are both turned on andthe cover is closed. If the system times-out before movement of thecover is detected, it returns to “Sleep Mode 1” (state 501). However, ifthe IR sensor module indicates that the cover is opened, the systemmoves to a “waiting for prime” state (state 505). Again, a systemtimeout can send the device into a “Sleep Mode 2” (state 507) where theIR sensor module is disabled to conserve power. Also, if the IR sensorsindicate that the cover is closed at this stage, the system returns to“Sleep Mode 1” (state 501). However, if the priming impulse is detectedby the accelerometer, the system moves to a “Record Audio/Inhalation”state (state 509) in which the microphone is also powered on. Audiorecording is terminated when either the cover is closed (as indicated bythe IR sensors) or when a timer expires. In either case, the systemmoves to the “Audio Data Processing” state (state 511) where themicrophone is powered off and the audio data is processed before beingsaved to memory.

After the data processing is complete, the system attempts to initiatewireless communication (entering the “Initiate Wireless Comm” state)(state 513). If communication fails, the system returns to either “SleepMode 1” (state 501) or “Sleep Mode 2” (state 503) depending on whetherthe IR sensor module indicates that the dispenser cover is open.However, if communication is successful, the system moves to a “WirelessComm” state (state 515) where data is wirelessly transmitted to aterminal device such as a cell phone carried by the user. Once data hasbeen successfully transmitted, it is deleted from the internal memory ofthe attachment device. After the wireless communication is complete, thesystem returns to either “Sleep Mode 1” (state 501) or “Sleep Mode 2”(state 507)—again, depending on whether the IR sensor module indicatesthat the dispenser cover is open.

Other constructions of the attachment may include additional sensors andfunctionality not illustrated or described above. Similarly, otherconstructions may include fewer sensors and few functional steps thanthose illustrated above. For example, in some constructions, steps 409and 411 of FIG. 4 are omitted. In such constructions, the attachmentdoes not monitor separately for a priming impulse and, instead, assumesthat medicament is dispensed based on either (1) the opening of themouthpiece (as detected by the IR sensor 305) or (2) the audible soundof the medicament being inhaled (as detected by the microphone 309).

Furthermore, in still other constructions, fewer sensors can beutilized. For example, in one construction, the IR sensor 307 isomitted, leaving only the accelerometer 305 and the microphone 309. As aresult, steps 405 and 407 of FIG. 4 are omitted. The attachment monitorsthe accelerometer 305 to determine when the device is being handled andthen activates the microphone 309. The microphone 309 is then monitorsfor the audible sound of the medicament being inhaled. Alternatively (orin addition), the output of the microphone 309 can be monitored todetermine a sound associated with the priming action of the dry powderinhaler (i.e., the sound of the pill being crushed or of the priminglever 109 being moved). Once the relevant sound is detected, theattachment determines that the medicament has been dispensed andtransmits relevant information to the cell phone (or other device).

In yet another construction, the microphone 309 is omitted and only theaccelerometer 305 and the IR sensor 307 remain. In such embodiments,step 413 is omitted from the method of FIG. 4. The accelerometer 305 isused to detect handling of the device and to detect a priming impulse(i.e., movement of the priming lever 109). The IR sensor 307 is used todetermine whether the mouthpiece of the inhaler is opened.Alternatively, the IR sensor 307 can be used to visually detect movementof the priming lever 109 (i.e., a dispensing of the medicament isdetected when the priming lever 109 breaks the IR beam emitted by the IRsensor 307).

In still another construction, the microphone 309 and the IR sensor 307are both omitted leaving only the accelerometer 305. In suchembodiments, the accelerometer 305 is used to detect handling of thedevice (i.e., steps 401 & 403) and is also used to detect the primingimpulse of the dispenser (steps 409 & 411). Steps 405,407, and 413 areomitted.

In another construction, the IR sensor is positioned to sense when themouth of the patient is placed in proximity to the mouthpiece duringmedication use.

In some constructions, the attachment device 200 may include additionalsensors to monitor galvanic skin response, oxygen saturation, and heartrate. These sensors can be passively activated, and their measurementsobtained, by the fingers either in the normal course of handling andusing the inhaler, or by activating specific buttons on the surface ofthe housing. Once these biometric parameters (for example, heart rate)are determined, the processor stores the data to the memory and attemptsto initiate a wireless communication link to send the data to thepatient's cell phone. Once the biometric data is sent, it is deletedfrom the local memory.

As described above, the wireless communication link is initiatedwhenever a usage event or heart rate event are concluded. The storedaudio data and/or heart rate data is then uploaded to the computerserver through a cell phone. However, in situations where a wirelesslink cannot be established, the data remains stored in the memory untilthe next wireless link is successfully established. Furthermore, in someconstructions, the attachment device stores further informationincluding, for example, a history of accelerometer readings thatindicate movement of the dispenser device. In some constructions, thisadditional accelerometer data is also uploaded to the computer serverwhenever a wireless link is established (i.e., after a medication usageevent or heart rate event).

Although not illustrated in the examples above, some constructions ofthe attachment device include a user interface. The user interface caninclude one or more indicators (e.g., LED, OLED, audible signals, visualsignals, etc.) that indicate information regarding the operation of theattachment device (e.g., low battery, wireless comm established, etc.).The user interface can also include various buttons that, for example,establish pairing between the attachment device and a particular cellphone or perform a factory reset of the device. Lastly, in someconstructions, the attachment device includes a vibration component thatvibrates to call the attention of the user.

The vibration feature and other components of the user interface can beused in conjunction with an application running on the user's cell phoneto help the user locate a lost dispenser. The user can initiate a signalfrom the cell phone that then causes the attachment device to vibrate,blink, or emit an audio signal.

Some constructions also utilize the user interface to notify the userwhen the attachment device is out of range and cannot establish awireless link with the user's cell phone. If the attachment device isunable to connect with the cell phone, an indicator—such as, forexample, a light, vibration, or tone—is initiated by the attachmentdevice. Similarly, an application can be run on the user's cell phonethat provides an indication on the cell phone when a link with theattachment device cannot be established. Therefore, the attachmentdevice notifies the user when the attachment device is being taken outof range of the cell phone and the cell phone can be configured tonotify the user when they are leaving the house without their medicationdispenser.

In some constructions, the attachment device is further configured todetermine whether the attachment device is coupled to a dispenser. Forexample, whenever the attachment device described above comes out of oneof the “Sleep Modes,” the IR sensor module will indicate whether adispenser is “opened,” “closed,” or “not attached.” In otherconstructions, the attachment device may include a mechanical switch oran ambient light sensor to detect whether the attachment device isproperly coupled to a dispenser.

The array of sensors described above can also be monitored to establisha “use profile.” In such constructions, the device will determine andstore indications of whether the device was recently opened (based onthe IR sensors), whether the device was recently primed/cocked (based onthe accelerometer and microphone), whether a sound was recorded thatcould be an inhalation, and whether each of these events occurred withina temporal window that indicates a normal usage of the medicationdispenser.

FIG. 6A illustrates the exterior of another construction of anattachment 600 for use with a medicament dispensing device such as theDiskus dry-powder inhaler. The attachment again includes an upper body601 and a lower body 603 connected by two side connection portions 605and 607. The external casing of the upper body 601 is generally circularwith a cut-out portion 609. The cut-out portion 609 provides greateraccess to the thumb grip 103 of the rotating dispenser body 101 (FIG.1A) as well as visual access to the dose counter 105 when the dispenseris in the closed position. When the dispenser is in the opened position,the cut-out portion 609 provides greater access to the mouthpiece 111.The lower body 603 also includes a pair of screw holes 611 used totighten pressure screws which are used to hold the attachment in placeon the dispenser, as described in greater detail below. In someconstructions, the upper body 601 or lower body 605 also includes acut-out (not pictured) to ensure that a dose counter on the dispensingdevice is not covered by the attachment 600.

FIG. 6B provides a top view of the attachment 600. This view betterillustrates the shape of the upper body 601 (including the cut-outportion 609). It also illustrates the shape of the side connectionportions 605, 607 which join the upper body 601 to the lower body 603.As shown in FIG. 6B, the side connection portions 605, 607 are generallyformed to conform to the shape of the medicament dispenser. The two sideconnection portions 605, 607 are separated by an opening 613 which canbe used to push the dispenser out of the attachment 600 as necessarywhen the dispenser is being removed from the attachment 600.

FIG. 6C shows the attachment 600 from the bottom. As shown in FIG. 6C,the upper body 601 extends beyond the lower body 603. Furthermore, fromthe bottom, the pair of friction screws 615, 617 can be seen. When thedispenser is inserted into the attachment, the friction screws 615, 617are tightened into screw holes 611 to increase the friction between thedispenser and the upper body 601 of the attachment thereby securing theattachment 600 to the dispenser. Although this discussion refers toscrews 615, 617 as “friction screws” that are used to secure thedispenser within the attachment, in other constructions, the size andmaterial of the attachment 600 is configured to hold the dispenserdevice in place by a friction fit without the use of screws. In somesuch constructions, screws 615, 617 may be used to secure an externalcover of the attachment 600 to the body of the attachment 600.

FIGS. 6D and 6E show the attachment 600 from the left and the rightsides. As shown in FIGS. 6D and 6E, the upper body 601 is thicker thanthe lower body 603. The upper body 601 is shaped to provide sufficientinternal space to hold the processor 301, the wireless transceiver 311,the memory 303, and the various sensors employed to monitor the usage ofthe dispenser.

As shown in FIG. 6F, the arrangement of the upper body 601, the lowerbody 603, and the side connection portions 605, 607 forms a largeopening 619 for receiving the dispenser. To couple the attachment 600 tothe dispenser, the cover 107 of the dispenser is inserted into thelarger opening 619 and the friction screws 615, 617 are tightened tohold the dispenser in place. As a result, the cover 107 is heldstationary relative to the attachment 600 while the dispenser body 101is allowed to rotate relative to the attachment 600.

As shown in FIG. 6G, the opening 613 is positioned opposite the largeropening 619. To decouple the attachment 600 from the dispenser, thefriction screws 615, 617 are loosened and the user inserts one or morefingers into the opening 613 to push the dispenser through the largeropening 619 on the opposite side, thereby disengaging the dispenser fromthe attachment 600.

Although the examples illustrated above discuss an attachment that isadapted to be coupled to a Diskus-type dry powder inhaler, the sensingfunctionality and arrangements described above can be applied to othertypes of medicament dispensers. For example, an accelerometer can beincorporated into an attachment for use with a canister-style metereddose inhaler such as the cap housing described in U.S. Pub. No.2009/0194104. Such an accelerometer can be used to detect dispensing ofthe medicament from the canister and then provide power to additionalelectronic components within the attachment.

FIG. 7A illustrates a construction of an attachment 800 configured foruse with a medicament dispenser device such as the Respimat soft mistinhaler (SMI) 700 developed by Boehringer Inhelheim. The Respimatdispenser 700 includes a main body 701 with a cavity for receiving amedication canister 703. A cover 705 is then placed over the canister703. Another cover 707 and a dispensing button 709 are positioned on theopposite end of the main body 701. The cover 707 is opened to reveal amouthpiece 711 underneath.

To prime the Respimat dispenser 700 for use, the cover 705 is rotatedrelative to the main body 701. This causes the medicament canister 703to move out of the cavity of the main body 701 along axis “A.” When thecover 707 is opened and the button 709 is pressed, the medicament isdispensed through the mouthpiece 711 as the canister moves into thecavity of the main body 701 along axis “A.”

The attachment 800 includes an external body 801 which is sized to fitaround the exterior of the rotatable cover 705 of the Respimat dispenserdevice 700. A printed circuit board 803 is positioned within theexternal body 801 and, in this example, includes a microphone 805, an IRsensor 807, and an accelerometer 809. However, in other constructions,the attachment 800 may be fitted with additional sensors, alternativesensors, or fewer sensors. Similarly, the sensor may have differentplacement in other constructions. A pair of button-type batteries 811 ispositioned at the distal end of the attachment and are electricallycoupled to the circuit board 803. A button 813 is also positioned on theexternal body 801 of the attachment 800.

A described above in reference to FIGS. 4 and 5, the accelerometer 809is used to bring the attachment out of a low-power “sleep mode” and tothen apply electrical power from the batteries 811 to the microphone 805and the IR sensor 807. Once out of the sleep mode, the IR sensor 807monitors for the movement of the medicament canister 703 through thetransparent cover 705 of the Respimat dispenser device 700. Theattachment determines that the medicament has been dispensed when thecanister 703 first moves to obstruct the IR sensor 807 and then movesagain to a position that does not obstruct the IR sensor 807. Oncedispensing is detected, the microphone 805 is activated to detect andmeasure sounds associated with the inhaled medicament. For example, theoutput of the microphone 805 can be used to measure inhalationcharacteristics of the patient using the medication and, together withapplication software running on the user's smartphone, provide feedbackto a doctor or the patient.

Alternatively, in other constructions, the IR sensor 807 is omitted,leaving only the microphone 805 and the accelerometer 809. In suchconstructions, the accelerometer is used to detect handling of theattachment 800 and the Respimat dispenser device 700. Once handling isdetected and power is applied to the microphone 805, the output of themicrophone 805 is monitored for a “click” sound associated with thepriming of the Respimat dispenser device 700 (i.e., the rotation of thetransparent canister cover 705) Alternatively, the output of themicrophone 805 can be monitored to detect when the button 709 of thedispenser device 700 is pressed indicating that medication has beendispensed.

In still other constructions, the positioning of the IR sensor 807 canbe moved such that the IR sensor detects compression and decompressionof a spring in the transparent base of the dispenser device 700 (whichindicates priming and movement of the medication canister). This can bein addition to or instead of the IR sensor 807 positioned to directlydetect canister movement from the side of the transparent base.

FIG. 7B shows an exploded view of the various components of theattachment 800. The Respimat dispenser device 700 fits into an internalreceiving body 815 of the attachment 800. The internal receiving body815 is sized and configured to be placed in close proximity with theexternal surfaces of the Respimat dispenser device 700 such thatrotation of the attachment 800 (and, therefore, rotation of the internalreceiving body 815) causes rotation of the transparent canister coverportion 705 of the Respimat dispenser device 700. A circuit board/logicportion 803 is formed to fit between the internal receiving body 815 ofthe dispenser and the external body 801. The attachment 800 may beconfigured to attach to the housing of the dispenser device 700 withoutrequiring adhesive material or excessive force and can be done in asingle one-step on/off procedure. The attachment housing design mayinclude clear material so no labeling of the dispensing device 700 iscovered. When attached, the attachment 800 does not interfere with orrestrict use of the dispensing device 700.

FIGS. 8A-8G illustrate another example of an attachment device 901 foruse with a Respimat-type medicament dispenser. As shown in FIG. 8A, theexternal surface of the attachment device 901 includes a substantiallycylindrical sheath body 903 and a top surface 905. As show in FIGS. 8Band 8C, the cylindrical sheath body 903 includes a slight beveledportion near the top surface 905 such that the diameter of the topsurface 905 is slightly smaller than the diameter of an opening at theopposite end of the sheath body 903. The sheath body 903 is also formedto include a protrusion 907 formed to receive a similarly shapedprotrusion of the transparent cover 705 of the Respimat dispenser device700. Another similarly sized protrusion 911 is formed on the oppositeside of the sheath body 903 (see, FIGS. 8C, 8D, and 8E). A button 909 ispositioned on the sheath body 903 near the top surface 905.

Thus, the invention provides, among other things, an attachment devicefor monitoring the usage of a medication dispenser. The attachmentdevice come out of a low-powered “sleep mode” when it detects that thedispenser is being handled and then provides power to additionalcomponents that consume more power. The attachment device can beconfigured to fit with a variety of different dispenser devicesincluding, for example, a canister-type metered dose inhaler, aDiskus-type dry powder inhaler, and a Respimat soft mist inhaler.Various features and advantages of the invention are set forth in thefollowing claims.

1. (canceled)
 2. A method of monitoring usage of a medicament dispenserwith a monitoring attachment, the method comprising: detecting, with aninfrared sensor of the monitoring attachment, a first signal indicativeof preparing to dispense medicament by the medicament dispenser, thefirst signal detected in response to movement of a body of themedicament dispenser relative to a cover in a first direction; inresponse to detecting the first signal, applying power to a microphoneof the monitoring attachment; recording audio captured by themicrophone; and transmitting a signal comprising the captured audio to amonitoring device for monitoring usage of the medicament dispenser. 3.The method of claim 2, wherein the infrared sensor is positioned todetect movement of a feature on the body, the feature selected from agroup consisting of: a ridge for air intake and a dose counter window,wherein the movement of the feature corresponds to movement of the bodyrelative to the cover.
 4. The method of claim 2, wherein the movement ofthe body relative to the cover in the first direction reveals amouthpiece of the medicament dispenser through which medicament may bedispensed.
 5. The method of claim 4, further comprising: detecting, withthe infrared sensor, a second signal indicative of closing of the cover,the second signal detected in response to movement of the body relativeto the cover in a second direction opposite the first direction whichoccludes the mouthpiece; and in response to detecting the second signal,ceasing to apply power to the microphone.
 6. The method of claim 2,wherein the movement of the body relative to the cover in the firstdirection corresponds to priming of the medicament dispenser which, whenprimed, can dispense medicament.
 7. The method of claim 2, wherein themovement of the body relative to the cover comprises a rotation of thebody relative to the cover.
 8. The method of claim 2, wherein recordingthe audio captured by the microphone comprises: recording a sound ofinhalation of medicament dispensed by the medicament dispenser.
 9. Themethod of claim 8, wherein recording the audio further comprises:recording a sound of priming of the medicament dispenser from movementof a priming lever of the medicament dispenser.
 10. The method of claim2, wherein the monitoring attachment is coupled to the cover and doesnot affect the movement of the body relative to the cover.
 11. Themethod of claim 2, further comprising determining a time and a date ofthe dispensing of the medicament, and wherein the signal furthercomprises the time and the date of the dispensing.
 12. A monitoringattachment attachable to a medicament dispenser for monitoring usage ofa medicament dispenser, comprising: a housing comprising an exteriorsurface attachable to a cover of the medicament dispenser, wherein themonitoring attachment does not affect operation of the medicamentdispenser; an infrared sensor configured to detect a first signalindicative of preparing to dispense medicament by the medicamentdispenser, the first signal detected in response to movement of a bodyof the medicament dispenser relative to a cover in a first direction; amicrophone configured to capture audio; a power control circuitconfigured to apply power to the microphone in response to detecting thefirst signal; and and a wireless transmitter configured to transmit asignal comprising the captured audio to a monitoring device formonitoring usage of the medicament dispenser.
 13. The monitoringattachment of claim 12, wherein the infrared sensor is positioned todetect movement of a feature on the body, the feature selected from agroup consisting of: a ridge for air intake and a dose counter window,wherein the movement of the feature corresponds to movement of the bodyrelative to the cover.
 14. The monitoring attachment of claim 12,wherein the movement of the body relative to the cover in the firstdirection reveals a mouthpiece of the medicament dispenser through whichmedicament may be dispensed.
 15. The monitoring attachment of claim 14,wherein the infrared sensor is further configured to detect a secondsignal indicative of closing of the cover, the second signal detected inresponse to movement of the body relative to the cover in a seconddirection opposite the first direction which occludes the mouthpiece;and wherein the power control circuit is configured to cease power tothe microphone in response to detecting the second signal.
 16. Themonitoring attachment of claim 12, wherein the movement of the bodyrelative to the cover in the first direction corresponds to priming ofthe medicament dispenser which, when primed, can dispense medicament.17. The monitoring attachment of claim 12, wherein the movement of thebody relative to the cover comprises a rotation of the body relative tothe cover.
 18. The monitoring attachment of claim 12, wherein the audiocaptured comprises a sound of inhalation of medicament dispensed by themedicament dispenser.
 19. The monitoring attachment of claim 18, whereinthe audio captured further comprises a sound of priming of themedicament dispenser from movement of a priming lever of the medicamentdispenser.
 20. The monitoring attachment of claim 12, wherein themonitoring attachment is coupled to the cover and does not affect themovement of the body relative to the cover.
 21. The monitoringattachment of claim 12, wherein the wireless transmitter is furtherconfigured to transmit a time and a date of the dispensing of themedicament with the signal.